502 Pharmaceutical Process Development and Pilot Plants


Description:
Papers are invited on experimental and theoretical studies on the development and scale-up of pharmaceutical processes. Cases involving models, statistical designs, process control, and analytical data acquisition are encouraged. Efforts can include, but are not limited to applications in small molecule and biologics API processing such as: crystallization, reactions, separations/purification, downstream processing, drying and size reduction. Studies in solid and liquid drug product manufacturing are also relevant such as direct compression, granulation, tablet/capsule production, liquid dosage formulations, softgels, parenterals, lyophilizaiton. Scale-up efforts are sought after in both aseptic and conventional GMP pilot plant settings

Sponsor:
Pilot Plants
Co-Sponsor(s):
Pharmaceutical Discovery, Development and Manufacturing Forum (26), Process Development Division (12)


Chair:
Onkar Manjrekar
Senior Scientist
AbbVie
Process research and Development
6108 Waterman blvd
North Chicago, IL
63112
Phone Number: 847-937-5073
Email: onkar.manjrekar@abbvie.com

Co-Chair:
Elie Chaaya
Engineer
Merck & Co. Inc.
Rahway, NJ
07065
Email: elie.chaaya@Abbvie.com


Papers:
Scale-up Modelling and Analysis of a Pharmaceutical Crystallization Process
Merve Öner, Technical University of Denmark; Getachew S. Molla, Technical University of Denmark; Michael Frederick Freitag, LEO Pharma A/S; Stuart Michael Stocks, LEO Pharma A/S; Jens Abildskov, Technical University of Denmark; Gürkan Sin, Technical University of Denmark
Removal of Impurity from API and Reduction of Agglomeration during Drying
Onkar Manjrekar, AbbVie; Howard E. Morton, AbbVie; Jie Chen, AbbVie; Lijie Cui, AbbVie; David Barnes, AbbVie; Jose Napolitano, AbbVie; Jeff Hartnell, AbbVie; Jeff Bien, AnnVie; Elie Chaaya, Merck & Co. Inc.; Subramanya Nayak, AbbVie; Shailendra Bordawekar, AbbVie Inc.
Viscoelastic Properties and Dissolution Kinetics of Amorphous Drug Dispersion Films, Utilizing the Quartz Crystal Microbalance
Mark A. Isbell, imperial college london; Geoff G. Z. Zhang, AbbVie Inc.; J.Y.Y. Heng, Imperial College London
Improving the Dissolution of Ibuprofen By Co-Milling of Ibuprofen and MCC Mixture in a Ball Mill
Sophia Varghese, Indian Institute of Technology Gandhinagar; Chinmay Ghoroi, Indian Institute of Technology Gandhinagar
Abstract Submissions Closed
See more of this Group/Topical: Process Development Division